MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER SAFETI PLUS WITH LUER-LOCK & LUER

Model Number 158100410190

Device Problem Restricted Flow rate (1248)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/26/2015

Event Type  malfunction  

Event Description

It was reported the urinometer 'measuring chamber empties slowly to the collector bag, independently of' the position of the open/close lever.No patient consequences were reported as a result of this event.

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.There were no reports of the patient being harmed as a result of this malfunction.Additional patient/event details have been requested.Should additional information become available, a follow-up report will be submitted.This complaint involves five devices, therefore a separate fda form 3500a will be drafted for each device.

• Brand Name: UNOMETER SAFETI PLUS WITH LUER-LOCK & LUER
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street 50; fanipol; dzerzhinsk district minsk region 00002 2275; BO 0000222750
• Manufacturer Contact: matthew walenciak, interim assoc. ; 211 american ave.; greensboro, NC 27409-0000 ; 9083779293
• MDR Report Key: 4810782
• MDR Text Key: 5920124
• Report Number: 3007966929-2015-00049
• Device Sequence Number: 1
• Product Code: EXR
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K896732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2018
• Device Model Number: 158100410190
• Device Lot Number: 655189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1